Model Number 133650 |
Device Problems
Material Deformation (2976); Mechanics Altered (2984)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, while being applied to clamp the vessel during an open thyroidectomy, the clips of the three devices did not come out crossing each other.The surgeon could not use these three devices, therefore used others from another supplier and the case was completed.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The first instrument was received fully applied.Visual inspection of the instrument revealed no abnormalities.Functionally, the empty cartridge precludes firing evaluation; however, the interlock was engaged and properly prevented the jaw from approximating.The second instrument was received partially applied with thirteen remaining clips.Visual inspection of the instrument revealed no abnormalities.Functionally, the instrument was fired once in air and proper clip formation was confirmed.The remaining clips were then fired on test media with proper formation.The jaw and handle moved smoothly through the firing cycle and returned to the open position and each remaining clip loaded properly in the jaw.When the cartridge was empty, the interlock engaged and prevented the jaw from approximating.Note that the information for use brochure which accompanies each product shipment cautions the user as follows: ensure that the handles are squeezed together firmly as far as they will go.Failure to squeeze the handles completely can result in clip malformation and possible bleeding or leakage.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, while being applied to clamp the vessel during an open thyroidectomy, the clips of the three devices did not come out or came out crossing each other.The surgeon could not use these three devices and therefore used others from another supplier and the case was completed.There was no patient injury.
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Search Alerts/Recalls
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